| Title： | Clinical Practice Guidelines for Colorectal Cancer Biomarker Testing |
| Edition： | Original |
| Classification： | Standard guideline |
| Field： | Diagnosis |
| Countries and regions： | China |
| Guidelines users： | Clinical specialists involved in the treatment of colorectal cancer include: oncologists, surgeons, and proctologists. Pathology team members specializing in colorectal cancer include: diagnostic pathologists, molecular diagnostics specialists, and laboratory technicians. |
| Evidence classification method： | Strongly Recommended: Supported by robust clinical research (multiple rigorous meta-analyses or large randomized controlled trials) with conclusions unlikely to be overturned by future studies. Recommended: Clear results but with some limitations in the body of evidence (such as multiple small published studies), where conclusions may change as more evidence accumulates. Consider: Practices or treatments where there is relatively insufficient evidence-based medicine(such as preclinical trials or a few case reports), but expert panels believe they are acceptable due to potential benefits or lack of better alternatives. Do Not Recommend: Practices or treatments that lack sufficient evidence, and therefore are not recommended until more data becomes available. |
| Development unit： | PQCC，Chinses Society of Pathology |
| Registration time: | 2024-10-17 |
| Registration number： | PREPARE-2024CN847 |
| Purpose of the guideline: | Colorectal cancer (CRC) remains one of the primary malignant tumors threatening human health. According to global cancer statistics, there were 19.96 million new cases of cancer in 2022, with colorectal cancer still ranking among the top three cancers by incidence. The National Cancer Center released data on the burden of malignant tumors in China for 2022, showing that colorectal cancer was the second most common new cancer diagnosis, with as many as 517,100 new cases (307,700 in males and 209,400 in females), and 240,000 deaths. In the era of precision medicine, the emergence of targeted therapy and immunotherapy has brought new hope to patients with colorectal cancer, and molecular marker testing plays an increasingly important role in clinical diagnosis and treatment. Accurate molecular marker testing is a prerequisite for achieving precise diagnosis and treatment of colorectal cancer. A nationwide multi-center clinical epidemiological study conducted in 2022 showed that the detection rates for RAS, BRAF, and MSI among patients with advanced colorectal cancer in our country were 41.4%, 36.1%, and 28.2%, respectively, indicating significant room for improvement in the standardization of colorectal cancer molecular marker testing. Following the publication of the "Expert Consensus on Molecular Biomarker Testing for Colorectal Cancer" in 2018, the Chinese Medical Association's Pathology Branch and the National Pathology Quality Control Center jointly established a multidisciplinary working group to develop guidelines for molecular biomarker testing in colorectal cancer. The working group, based on recent evidence from evidence-based medicine and following the principles and methods recommended by the World Health Organization for guideline development, has been engaged in writing the guidelines covering clinical application, testing methods, and quality control of molecular markers. This guideline aims to provide healthcare professionals with the latest scientific evidence and clinical practice recommendations regarding biomarker testing in colorectal cancer, to enhance diagnostic accuracy, optimize treatment decisions, and ultimately improve patient outcomes. |
Latest registration
